This is a continuation of an existing, well-functioning and absolutely essential Core. During the previous funding period, the Core provided extensive biostatistical and data management support to all five projects, to both the Pathology Core and the Tumor Bank Core, and to several of the Developmental Projects, resulting in more than 30 coauthored publications, many in high impact journals. All projects in our new SPORE application will require substantial statistical support for a range of preclinical and clinical experiments. In our experience, centralized biostatistical support ensures that the biostatisticians are completely familiar with all aspects of the Projects and Cores. This provides continuity, increases efficiency, and ensures that appropriate methods are applied. The specific aims of the Core B (Biostatistics and Data Management) are to: (1) Provide comprehensive biostatistical and bioinformatical consultation, data analysis and reporting; (2) Provide comprehensive support for conduct and analysis of clinical trials, including data quality control and monitoring, interim monitoring and analysis of data, final analysis, and reporting; (3) Develop and maintain databases and database applications in support of Projects and Cores. The SPORE benefits greatly from having a dedicated and experienced team of analysts with a range of skills. For example, analysis of microarray experiments is especially demanding and complex and will require both biostatistical and bioinformatic expertise. Core analysts are active participants in all aspects of the SPORE. Sample size considerations, experimental designs, and overviews of planned analyses for all projects were prepared in collaboration with the Core, and are provided within each project and specific aim. In addition, deep understanding of Project and Core data and analysis needs, in turn, drives database development, ensuring that database solutions meet the broad as well as project-specific needs of the SPORE. Core personnel can also help the investigators design new studies and test new hypotheses that may arise by cross-fertilization of these related projects. Finally, Core leaders are highly experienced biostatisticians, who have longstanding collaborative relationships with all SPORE investigators and other Core leaders, and who are members of the Biostatistics Shared Resource of the Dan L. Duncan Cancer Center at Baylor College of Medicine, thus facilitating a close integration with the Cancer Center.